Lurbinectedin Plus Paclitaxel Versus Paclitaxel in Patients With Previously Treated Small Cell Lung Cancer

NCT07640932 | Not Yet Recruiting Phase 2

• 1 other identifier: 4-2025-1042
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is designed to compare and evaluate the efficacy and safety of the combination therapy of Lurbinectedin plus Paclitaxel (Combination Arm) versus Paclitaxel monotherapy (Monotherapy Arm) in patients with extensive-stage small-cell lung cancer whose disease has progressed after first-line chemotherapy.

Conditions

Carcinoma, Small Cell Lung

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR is defined as the percentage of test subjects whose confirmed response was (RECIST 1.1) at least one full response (Complete Response, CR) or partial response (Partial Response, PR) before evidence of disease progression appears. The objective response rate is summarized for groups that can be evaluated for validity. The objective response rate is presented with a 95% confidence interval on both sides (assuming a normal distribution).

  End of trial(approximately 3years)

Secondary Outcomes (8)

• Progression-Free Survival (PFS) according to RECIST v1.1

  End of trial (approximately 3 years)

• PFS2 for the Two Regimens (Progression-Free Survival 2)

  End of trial (approximately 3 years)

• Overall survival (OS)

  End of trial (approximately 3 years)

• Disease control rate (DCR)

  End of trial (approximately 3 years)

• Duration of response (DoR)

  End of trial (approximately 3 years)

Study Arms (2)

Combination therapy of Lurbinectedin and Paclitaxel

EXPERIMENTAL

The study drugs are administered every 3 weeks until disease progression or unacceptable drug-related toxicity. Lurbinectedin is given IV at 2.2 mg/m² on Day 1, Paclitaxel IV at 80 mg/m² on Days 1 and 8, and Pegylated G-CSF on Day 2, about 24 hours after chemotherapy.

Drug: Lurbinectedin; Drug: Paclitaxel

Paclitaxel monotherapy

ACTIVE COMPARATOR

The study drugs are given every 3 weeks until disease progression or unacceptable drug-related toxicity. Paclitaxel is administered IV at 80 mg/m² on Days 1 and 8, and Pegylated G-CSF is given at the investigator's discretion.

Drug: Paclitaxel

Interventions

Lurbinectedin DRUG

Administered IV at 2.2 mg/m² on Day 1 every 21-day cycle until disease progression or unacceptable toxicity.

Combination therapy of Lurbinectedin and Paclitaxel

Paclitaxel DRUG

Administered IV at 80 mg/m² on Days 1 and 8 every 21-day cycle until disease progression or unacceptable toxicity.

Combination therapy of Lurbinectedin and Paclitaxel; Paclitaxel monotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 19 years.
• Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
• Patients who have experienced disease progression following at least one prior platinum-based systemic therapy for extensive-stage small cell lung cancer, including all of the following conditions:
• Patients who failed treatment within 6 months after curative-intent chemotherapy are considered as having failed first-line therapy.
• For platinum-sensitive patients, participation in the third-line cohort is allowed after re-treatment with a platinum-based regimen as second-line therapy (limited-stage).
• For platinum-resistant patients, participation in the second-line cohort is allowed (limited-stage).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• At least one measurable target lesion according to RECIST v1.1 criteria.
• Predicted life expectancy of at least 12 weeks (3 months).
• Adequate hematologic, renal, metabolic, and hepatic function within 14 days prior to enrollment, defined as:
• Absolute neutrophil count (ANC) ≥ 1,500/μL Platelet count ≥ 100,000/μL Hemoglobin (Hb) ≥ 9.0 g/dL Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated creatinine clearance (cCr) ≥ 60 mL/min Total bilirubin ≤ 1.0 × ULN AST and ALT ≤ 3.0 × ULN (regardless of liver metastasis) PT and aPTT ≤ 1.5 × ULN
• Willingness to provide unstained slides (minimum 5, ideally 15) from archived or freshly biopsied tissue for exploratory analyses.
• Female participants of childbearing potential must have a negative pregnancy test (urine) at screening. If the urine test is positive or inconclusive, a negative serum pregnancy test is required.
• Female participants of childbearing potential must agree to use effective contraception during the study.
• Male participants of reproductive potential must agree to use effective contraception during the study (see appendix for acceptable methods).

You may not qualify if:

• Patients who have not received prior systemic therapy for small cell lung cancer (SCLC).
• Patients previously treated with Lurbinectedin or Paclitaxel.
• Patients with limited-stage small cell lung cancer (LS-SCLC).
• Patients with symptomatic or clinically significant brain metastases (patients with asymptomatic or stable brain metastases may be eligible; any treatment for brain metastases must have been completed at least 1 week prior to the first dose of study drug).
• Concomitant use of medications that may prolong the QTc interval, potent immunosuppressive agents, or drugs that may cause interstitial lung disease (ILD) is prohibited during the treatment period. If co-administration is unavoidable, prior discussion with the coordinating center is required.
• Patients with active primary immunodeficiency (e.g., HIV infection), active hepatitis B, or active hepatitis C:
• HBsAg-positive patients may be eligible if HBV DNA is negative or appropriate antiviral therapy is being administered.
• HCV antibody-positive patients may be eligible if HCV RNA is negative or the patient has been cured after treatment.
• Patients with active interstitial lung disease (ILD) or a history of non-infectious pneumonitis requiring steroid therapy, including immune-therapy- or chemotherapy-related ILD or Grade ≥3 pulmonary complications. (Patients with previously resolved infectious pneumonia without current clinical significance may be eligible.)
• Pregnant or breastfeeding women.
• Patients with clinically significant cardiovascular disease within the past 12 months (e.g., congestive heart failure, symptomatic coronary artery disease, arrhythmias, myocardial infarction).
• Patients whose toxicities from prior anticancer therapy have not recovered to baseline or ≤ Grade 2.
• Patients who received any prior anticancer therapy within 14 days or localized radiotherapy within 7 days before the first dose of the study drug.
• Patients with a known hypersensitivity to the study drugs.
• Any condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

PM 01183; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Hye Ryun Kim

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hye Ryun KIM

CONTACT

82-2-2228-8125; nobelg@yuhs.ac

Chang Gon kim

CONTACT

82-10-9162-1729; inspector@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: June 11, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)